Methods for reshaping cartilage structures

ABSTRACT

Described are methods and systems for reshaping a cartilage structure. Such methods comprise treating the cartilage structure with electromagnetic energy and fitting a device to the cartilage structure to retain it in the desired place, form, and/or orientation. Systems comprise an emitter of electromagnetic energy and a device to the cartilage structure to retain it in the desired place, form, and/or orientation.

TECHNICAL FIELD

The invention relates to systems and methods for reshaping cartilagestructures, such as a human or mammalian ear, for example as a cosmetictreatment.

BACKGROUND

Ear deformations affect 5% of the Caucasian and Latino population or12.1 million people (5% of 242.3 million). Each year, 4.26 millionchildren are born of white or Latino parents (2.3 million whites and 1million Hispanics). Of these, approximately 165,000 are born withdeformed ears.

However, according to the American Society of Plastic Surgeons (ASPS),only 29,434 cosmetic ear surgery procedures were performed in 2009 inthe US and these were primarily performed on children, leaving the vastmajority of the population untreated (it is interesting to note thatotoplasty is the only cosmetic procedure performed on children,testifying to the damaging psychological issues stemming from thiscondition).

The average child has 85% ear development by 3 years of age and ears aretypically fully grown by the age of 7 years (the height continues togrow into adulthood, but the width and distance from ear to scalpchanges little). This fact in part explains why this procedure ispopular with children, as procedures performed from this age onwardswill yield permanent results.

All ears also have surprisingly similar features in terms of size,protrusion from the scalp and angle from the cranium. The following is alist of considered standard sizes: fully grown ears protrude from thescalp about 1.8-2.0 cm at midpoint; ear length is typically 5.5-6.5 cm;ear width is typically 3.0-4.5 cm; the ratio between width and length isabout 50% to 60%; helical Rim (Helix) 7 mm or about 10% of the height;ear vertical axis 15 to 30 degrees posterior (with the top further backthan the bottom).

Features constituting what is considered “normal” ear features are:scapha angle greater than 90 degrees; conchal bowl height less than 1.5cm; and angle head to ear: female less than 21 degrees and male lessthan 25 degrees.

Ear deformations typically fall into two broad categories, cartilagedeformations and non-cartilage related deformations. Cartilagedeformations include prominent (or bat) ears which typically is aproblem either of an oversized concha, or too wide an antihelical foldangle or a combination of the two; helical deformations that include:constricted ear including hooding or folding of the helical rim; lop earwhere the top of the ear is folded down and forward; cup ear includingmalformed protruding ear with the top folded down and a large concha;shell ear where curve of the outer rim as well as the folds and creasesare missing; and stahl's ear (Spock's ear) where there is an extra foldand pointed top. Non-cartilage related deformations include: lobedeformations, macrotia (oversized ears), and microtia (undersized ears).

Surgical Ear Correction: Otoplasty

The first otoplastic technique to correct protruding ears is attributedto Ely in 1881. Since that report, over 180 surgical techniques havebeen described in the literature for the correction of protruding ears.These techniques can be subdivided into 3 sub-groups:

“Suture only” technique: First described by Furnas in 1968 (and stillused to this day), this technique is used primarily to set back the earsand involves retracting the skin behind the ear and place 2-3non-resorbable sutures to retract the position of the ear. The Mustardemethod is today the most common.

Cartilage splitting or weakening technique or “Davis” method: Excisionof skin and cartilage to correct conchal hypertrophy.

Combination of the above two or “converse Wood-Smith” technique: uses acartilage cutting and suture method to correct and create ananti-helical fold.

All these surgical techniques tend to be performed on an outpatientbasis under sedation, although when dealing with children it isadvisable to perform it under general anesthesia. The procedure isgenerally performed primarily by Facial Plastic Surgeons and, to alesser extent by Dermatologists, ENT and Maxillofacial Surgeons. Ittypically takes 2 to 3 hours to perform and is not without risks.

Major complications from corrective ear surgery may occur and can bedivided into two categories: immediate complications: hematoma andinfection that may result in necrosis; and long-term complicationsinclude hypertrophic (keloid) scars, loss of sensitivity (resulting fromdamage to nerve endings), skin and cartilage necrosis as well asunaesthetic results or recurrence of the ear deformity. Thesecomplications are responsible for the high (10%) rate of repeatsurgeries.

BRIEF SUMMARY

Described herein are methods and systems for shaping or reshaping acartilage structure, the method comprising treating the cartilagestructure of a subject with electromagnetic energy of from 50 to 1200 nmor 2100 of from 250 to 1315 nm, 1325 to 1445 nm or 1455 to 1535 nm or1540 at 11 J/cm² or less, or 1540 at 13 J/cm² or higher, 1545 to 2095 or2105 to 10600 nm wavelength; and fitting the treated cartilage structurewith a device designed to retain the cartilage structure in a desiredorientation, shape, and/or location.

Also described herein are methods and systems for shaping or reshaping acartilage structure, the method comprising treating the cartilagestructure of a subject with electromagnetic energy of from 1 KHz to 200MHz; and fitting the treated cartilage structure with a device designedto retain the cartilage structure in a desired orientation, shape,and/or location.

Further described herein are methods and systems for shaping orreshaping a cartilage structure, the method comprising treating thecartilage structure of a subject with a total fluence of from 1 to 60 orfrom 90 to 100 Joules of electromagnetic energy per unit area; andfitting the treated cartilage structure with a device designed to retainthe cartilage structure in a desired orientation, shape, and/orlocation.

Additionally, described herein are methods and systems for shaping orreshaping a cartilage structure, the method comprising exposing thecartilage structure, or the area surrounding a cartilage structure, of asubject to trauma; and fitting the treated cartilage structure with adevice designed to retain the cartilage structure in a desiredorientation, shape, and/or location.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a depiction of one embodiment of system including an emitterand a device designed to retain the cartilage structure in a desiredorientation, shape, and/or location.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments include methods and systems for forming or reformingcartilage structures in a subject. The forming or reforming of cartilagestructures may take place through the process of chondrogenesis. Thecartilage structures may be any cartilage-containing portion of asubject including, but not limited to, the joints between bones, the ribcage, the ear, the nose, the elbow, the knee, the ankle, the bronchialtubes, the intervertebral discs, and nasal septum. One example of such amethod comprises treating a cartilage structure with a laser so as tostimulate chondrogenesis as described by Leclere et al. (Aesth. Plast.Surg. April 2010; 34(2):141-6); Mordon et al. (Lasers Surg. Med. 200434:315-322) and Mordon et al. (Lasers Surg. Med. August 2006;38(7):659-62) the contents of the entirety of each of which areincorporated herein by reference.

Electromagnetic energy may be applied to the cartilage structure inorder to stimulate reformation of the cartilage structure. Before,during, or after the application of the electromagnetic energy, thecartilage structure may be fitted with a device designed to retain thecartilage structure in the orientation, shape, and/or location desiredafter the reforming of the cartilage structure. Examples of such devicesinclude, but are not limited to, those described in U.S. patentapplications Ser. Nos. 13/498,573 and 61/613,358, WO 2011/129900 (filedOct. 20, 2011), and PCT/US2013/032182, (filed Mar. 15, 2013) thecontents of the entirety of each of which are incorporated herein byreference.

A device designed to retain the cartilage structure in the orientation,shape, and/or location desired may be of the form depicted in FIG. 1. Ashown therein, a device may comprise a ear device (1) fitting over thehelix of the outer ear and a projection (2) originating and attached tothe ear device (1) at its proximal end (3) and extending across theanti-helix and the distal end (4) fitting into the scapha under thehelix at about the lower ems of the anti-helix and/or the fossatrangularis. The projection (2) and ear device (1) may be formed as asingle piece or multiple pieces.

The electromagnetic energy (5) may be applied to the cartilage structurein the form of laser light, e.g., via an emitter (6). The laser lightmay be from about 450 to about 10600 nm in wavelength or from 450 to10600 nm in wavelength. The laser light may be from about 250 to 1315nm, 1325 to 1445 nm or 1455 to 1535 nm or 1540 at 11 J/cm² or less, or1540 at 13 J/cm² or higher, 1545 to 2095 or 2105 to 10600 nm wavelength.In particular, the laser light may specifically exclude wavelengths of1320 nm, 1450 nm, 1540 nm at 12 J/cm², or 2100 nm. The laser light maybe, e.g., 450, 500, 550, 600, 650 700, 750, 800, 850, 900, 950, 1000,1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2050, 2150,2200, 2300, 2400, 2500, 2600, 2700, 2800, 2900, 3000, 4000, 5000, 6000,7000, 8000, 9000, 10000, 10100, 10200, 10300, 10400, 10500, 10600, ormore nm in wavelength.

The laser emitter may be calibrated and/or independently determined toemit the desired wavelength before use. Before application of the laserto the cartilage structure, the wavelength of the laser light beingemitted may be determined. Determination of the wavelength, calibrationof the laser wavelength, and/or independent determination may be carriedout using equipment and procedures well known to those of ordinary skillin the art of lasers. For example, the power meters, energy sensors, andbeam profilers available from Ophir-Spiricon LLC (North Logan, Utah,USA) may be used to determine the wavelength, or calibrate the laser

Once the wavelength emitted has been determined, the laser may becalibrated to emit a wavelength as desired above. The laser may becalibrated to vary from a chosen wavelength by no more than, e.g., 1%,0.1%, 0.01%, 0.001%, 0.0001%, or 0.00001%. Instead of calibrating thelaser, the total fluence of energy applied, the number of pulses, and/orthe pulse length may be altered to compensate for the actual wavelengthemitted.

As depicted in FIG. 1, a system may comprise a laser emitter (6) thatemits laser light (5) as identified above and a device (e.g. (1)-(4))designed to retain the cartilage structure in the orientation, shape,and/or location desired. The tip of the laser may incorporate anintegrated cooling device such that when in use, the cooled tip of thedevice imparts a cooling effect on any tissue or cartilage structurebeing irradiated by the laser. One non-limiting example of such acooling tip is the Koolburst, available from Quantel Deima GmbH,Erlangen Germany utilizing the manufacturer's instructions.

The electromagnetic energy may be applied to the cartilage structure inthe form of lower power waves. The lower power waves may be from about1000 Hz to about 50 MHz or from 1000 Hz to 50 MHz. The lower power wavesmay be from about 300 KHz to about 200 MHz or from 300 KHz to 200 MHz.

The lower power wave emitter may be calibrated and/or independentlydetermined to emit the desired Hz before use. Before application of thelaser to the cartilage structure, the Hz of the electromagnetic energybeing emitted may be determined. Determination of the Hz, calibration ofthe emitter, and/or independent determination may be carried out usingequipment and procedures well known to those of ordinary skill in theart. For example, the power meters, energy sensors, and beam profilersavailable from Ophir-Spiricon LLC (North Logan, Utah, USA) may be usedto determine the Hz and/or calibrate the emitter.

Once the Hz emitted has been determined, the emitter may be calibratedto emit a wavelength as desired above. The emitter may be calibrated tovary from a chosen Hz by no more than, e.g., 1%, 0.1%, 0.01%, 0.001%,0.0001%, or 0.00001%. Instead of calibrating the emitter, the totalfluence of energy applied, the number of pulses, and/or the pulse lengthmay be altered to compensate for the actual Hz emitted.

A system may comprise a lower power wave emitter that emitselectromagnetic energy as identified above and a device designed toretain the cartilage structure in the orientation, shape, and/orlocation desired.

One or more pulses or electromagnetic energy may be applied to aparticular area of the cartilage structure in an individual treatment.The number of pulses to a particular cartilage area may be, e.g., 1, 2,3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22,23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40,41, 42, 43, 44, 45, 46, 47, 48, 49, 50, or more. The number of pulsesmay be between 1 and 50. In particular, 7 pulses may be specificallyexcluded.

The pulse length of the application of the electromagnetic energy may bevaried. The pulse length may be from 1 nanosecond to 1 second. Further,the pulse length may be from 1 microsecond to 500 milliseconds. Thepulse length may be, e.g., 1, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90,100, 150, 200, 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750,800, 850, 900, 950, or 1000 nanoseconds. Further, the pulse length maybe, e.g., 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 150, 200, 250, 300,350, 400, 450, 500, or more milliseconds.

The electromagnetic energy emitter may be calibrated and/orindependently determined to emit the pulse length before use. Beforeapplication of the electromagnetic energy to the cartilage structure,the pulse length of the electromagnetic energy being emitted may bedetermined. Determination of the pulse length, calibration of theemitter, and/or independent determination may be carried out usingequipment and procedures well known to those of ordinary skill in theart. For example, the power meters, energy sensors, and beam profilersavailable from Ophir-Spiricon LLC (North Logan, Utah, USA) may be usedto determine the pulse length and/or calibrate the emitter.

Once the pulse length emitted has been determined, the emitter may becalibrated to emit a pulse length as desired above. The emitter may becalibrated to vary from a chosen pulse length by no more than, e.g., 1%,0.1%, 0.01%, 0.001%, 0.0001%, or 0.00001%. Instead of calibrating theemitter, the total fluence of energy applied, the number of pulses,and/or the wavelength of the electromagnetic energy may be altered tocompensate for the actual pulse length emitted.

A system may comprise an electromagnetic energy emitter that emitselectromagnetic energy in pulses of the desired length as identifiedabove and a device designed to retain the cartilage structure in theorientation, shape, and/or location desired. The electromagnetic energyemitter may be calibrated and/or independently determined to emit pulsesof the desired length.

Where multiple pulses are used, the interval between pulses may bevaried. The interval length may be from 1 nanosecond to 1 second.Further, the interval length may be from 1 microsecond to 500milliseconds. The interval length may be, e.g., 1, 5, 10, 20, 30, 40,50, 60, 70, 80, 90, 100, 150, 200, 250, 300, 350, 400, 450, 500, 550,600, 650, 700, 750, 800, 850, 900, 950, or 1000 nanoseconds. Further,the interval length may be, e.g., 10, 20, 30, 40, 50, 60, 70, 80, 90,100, 150, 200, 250, 300, 350, 400, 450, 500, or more milliseconds. Theelectromagnetic energy emitter may be calibrated and/or independentlydetermined to emit pulses at an interval of the desired length beforeuse.

A system may comprise an electromagnetic energy emitter that emitselectromagnetic energy in pulses at an interval of the desired length asidentified above and a device designed to retain the cartilage structurein the orientation, shape, and/or location desired. The electromagneticenergy emitter may be calibrated and/or independently determined to emitpulses at an interval of the desired length.

The amount of electromagnetic energy delivered per pulse may vary. Forexample, a pulse may apply, e.g., 0.01, 0.02, 0.03, 0.04, 0.05, 0.06,0.07 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3,4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22,23, 24, 25, 26, 27, 28, 29, 30, or more Joules per pulse. The amount ofelectromagnetic energy may be from about 0.1 to about 30 Joules perpulse or from 0.1 to 30 Joules per pulse. Further, the amount ofelectromagnetic energy may be from about 0.1 to about 10 Joules perpulse or from 0.1 to 10 Joules per pulse. In particular, energy valuesof 0.1, 0.2, 0.3, 0.4, 2, 12, and 14 Joules per pulse may bespecifically excluded.

The electromagnetic energy emitter may be calibrated and/orindependently determined to emit the chosen Joules/pulse before use.Before application of the electromagnetic energy to the cartilagestructure, the Joules/pulse emitted may be determined. Determination ofthe Joules/pulse, calibration of the emitter, and/or independentdetermination may be carried out using equipment and procedures wellknown to those of ordinary skill in the art. For example, the powermeters, energy sensors, and beam profilers available from Ophir-SpiriconLLC (North Logan, Utah, USA) may be used to determine the Joules/pulseand/or calibrate the emitter.

Once the Joules/pulse emitted has been determined, the emitter may becalibrated to emit a Joules/pulse as desired above. The emitter may becalibrated to vary from a chosen Joules/pulse by no more than, e.g., 1%,0.1%, 0.01%, 0.001%, 0.0001%, or 0.00001%. Instead of calibrating theemitter, the total fluence of energy applied, the number of pulses,and/or the wavelength of the electromagnetic energy may be altered tocompensate for the actual Joules/pulse emitted.

A system may comprise an electromagnetic energy emitter that emitselectromagnetic energy at a desired Joules/pulse as identified above anda device designed to retain the cartilage structure in the orientation,shape, and/or location desired. The electromagnetic energy emitter maybe calibrated and/or independently determined to emit the desiredJoules/pulse.

The cumulative electromagnetic energy delivered to a unit area may vary.The cumulative electromagnetic energy delivered is the sum of the energydelivered by one or more pulses to a particular area. The cumulativeelectromagnetic energy may be, e.g., 1, 5, 10, 15 20, 25, 30, 35, 40,45, 50, 55, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74,75, 76, 77, 78, 79 80, 81, 82, 83 84, 85, 86 87, 88, 89, 90, 91, 92, 93,94, 95, 96, 97, 98, 99, 100, 110, 120, 130, 140, 150, 160, 170, 180,190, 200, 250, 300, 350, 400, 450, 500, 600, 700, 800, 900, 1000 or moreJoules per unit area. The cumulative electromagnetic energy delivered toa particular area may be from about 50 to about 100 Joules or from 50 to100 Joules. For example, the cumulative electromagnetic energy deliveredto a particular area may be from about 60 to about 90 Joules or from 60to 90 Joules. For example, the cumulative electromagnetic energydelivered to a particular area may be from about 65 to about 75 Joulesor from 65 to 75 Joules. The cumulative electromagnetic energy deliveredto a particular area may be from about 1 to about 60 Joules or from 1 to60 Joules. The cumulative electromagnetic energy delivered to aparticular area may be from about 90 to about 150 Joules or from 90 to150 Joules. The cumulative electromagnetic may specifically exclude 70or 84 Joules. The electromagnetic energy emitter may be calibratedand/or independently determined to emit the desired amount of Joules persingle/or cumulative pulses before use.

The electromagnetic energy emitter may be calibrated and/orindependently determined to emit the chosen cumulative electromagneticenergy before use. Before application of the electromagnetic energy tothe cartilage structure, the cumulative electromagnetic energy emittedmay be determined. Determination of the cumulative electromagneticenergy, calibration of the emitter, and/or independent determination maybe carried out using equipment and procedures well known to those ofordinary skill in the art. For example, the power meters, energysensors, and beam profilers available from Ophir-Spiricon LLC (NorthLogan, Utah, USA) may be used to determine the cumulativeelectromagnetic energy and/or calibrate the emitter.

Once the cumulative electromagnetic energy emitted has been determined,the emitter may be calibrated to emit a cumulative electromagneticenergy as desired above. The emitter may be calibrated to vary from achosen cumulative electromagnetic energy by no more than, e.g., 1%,0.1%, 0.01%, 0.001%, 0.0001%, or 0.00001%. Instead of calibrating theemitter, the length of the pulses, the number of pulses, and/or thewavelength of the electromagnetic energy may be altered to compensatefor the actual cumulative electromagnetic energy emitted.

A system may comprise an electromagnetic energy emitter that emitselectromagnetic energy at a desired amount of Joules per single/orcumulative pulses as identified above and a device designed to retainthe cartilage structure in the orientation, shape, and/or locationdesired. The electromagnetic energy emitter may be calibrated and/orindependently determined to emit the desired amount of Joules persingle/or cumulative pulses.

The target cartilage may be part of a human or a non-human animal.Alternatively, the target cartilage may be present in culture.

The location, environment, and state of the cartilage structure mayrequire different wavelengths, Hz, cumulative electromagnetic energy,number of pulses, Joules/pulse, and/or intervals between pulses. Theabove parameters may be varied so as to achieve the best cartilageremodeling and/or decreased side effects from the methods.

The device designed to retain the cartilage structure in theorientation, shape, and/or location may have its surface impregnatedwith various factors known to effect the growth and maturation ofcartilage such as, but not limited to, IGF-I, TGF-beta1, BMP-7, PDGF-AB;and FGF-2.

The application of electromagnetic energy to the cartilage structure maycomprise application to one or more of the surfaces of the cartilagestructure. By way of non-limiting examples, application ofelectromagnetic energy to the ear may comprise lasing of both sides ofthe ear at the location to be stimulated, for example both sides of theentire helix and concha of the ear; application of electromagneticenergy to the nasal septum may comprise application to both surfaces ofthe septum; and application of electromagnetic energy to a spinal discor meniscus of the knee may comprise application to all or some of thesurfaces of these structures. The locations on a cartilage structure tobe subject to the application of electromagnetic energy may include theentire structure or may be limited to particular portions of a cartilagestructure in order to achieve a desired localization of chondrogenesis.

In addition, trauma may be applied to a cartilage structure or to thearea around a cartilage structure in order to stimulate chondrogenesisin the cartilage structure. The trauma may be precisely localized to aparticular area or may be diffuse. The locations on a cartilagestructure to be subject to the trauma may include the entire structureor may be limited to particular portions of a cartilage structure inorder to achieve a desired localization of chondrogenesis. The traumamay include but is not limited to blunt trauma, piercing trauma, andthermal trauma. Blunt trauma may include but is not limited to traumacaused by a physical impact or by shockwaves. Piercing trauma mayinclude the application of one or more needles or microneedles to thecartilage structure or the area around the cartilage structure. Thermaltrauma may be either cold trauma or heat trauma and may be applied bylowering or raising the temperature of the cartilage structure or thearea surrounding it. Further, the temperature may be raised by impartingenergy to the molecules of the cartilage structure or surrounding areaby using electromagnetic radiation such as laser light or microwaves.Before, during, or after the application of the trauma, the cartilagestructure may be fitted with a device designed to retain the cartilagestructure in the orientation, shape, and/or location desired after thereforming of the cartilage structure.

It is intended that chondrogenesis may be stimulated in a cartilagestructure by one or more of the methods described herein either seriallyor in parallel. Further, chondrogenesis may be stimulated by a singletreatment or by multiple treatments by one or more of the methoddescribed herein in order to achieve the desired remodeling of thecartilage structure.

The device designed to retain the cartilage structure in theorientation, shape, and/or location may be placed on the cartilagestructure and left in place until the cartilage structure is effectivelyreshaped by the device. The device may be left in place for a period of3 to 6 weeks. The device may be worn continuously for the first 3 weeksand then only at night for an additional 3 weeks.

All elements described herein may be combined with any other elementdescribed herein. As such, all possible combinations of elementsdescribed herein, even if not explicitly set forth, are specificallyincluded.

EXAMPLE 1

Laser-Assisted Cartilage Reshaping for Treating Ear Protrusions

Materials and Methods

Twenty-four subjects were treated by LACR. All subjects were informed ofthe purpose and possible outcomes of the study, signed forms of consentfor the study, and agreed to clinical photography. There were 14 adultsand 10 children. The subjects' mean age was 16.0 years (range=6-45years). Pain was assessed by the subjects using a 4-point scale: none,slight, moderate, or severe

For 21 subjects, the 1540 nm Er:YAG laser (Aramis, Quantel Derma GmbH,Erlangen, Germany) was set at 12 J/cm2 per pulse. The treatmentconsisted of seven stacked pulses (3 ms, 2 Hz, 84 J/cm2 cumulativefluence) applied using a 4-mm spot hand piece with integrated cooling(Koolburst, Quantel Derma GmbH, Erlangen, Germany) on both sides of theentire helix and concha. For the remaining three adults, the laser wasset at a lower fluence of 10 J/cm2 per pulse for a total cumulativefluence of 70 J/cm2. The entire helix and concha were irradiated on bothsides. Contact cooling made the treatment very tolerable, to the extentthat topical anesthesia was not required (although local anestheticcertainly could have been used).

Twenty-four subjects underwent LACR of both ears using our 1.54-lmlaser. Immediately after irradiation, a silicone elastomer (Hydro-C,Detax, Ettlingen, Germany) was inserted inside the helix to give it thedesired shape. Three minutes later the elastomer hardened and a solidmold was obtained. The entire procedure took no more than 15-20 min perear. Subjects were asked to wear this mold at all times for the first 3weeks and then only at night for an additional 3 weeks. A non-steroidalanti-inflammatory drug (NSAID) was provided to all subjects for 3 days.Ears were checked at days 1, 30, 60, and 90 and photographs were taken.Clinical follow-up at 1 year was obtained via direct contact (n=22) orover the telephone (n=2).

Results

Postoperative follow-up was uneventful for all ears, except for six onwhich minor contact dermatitis developed probably because ofinappropriate mold design. This did not require additional therapy andthose subjects (4 children and 2 adults) stopped wearing the moldleading to incomplete shape correction. There were no cases of infectionhematomas or skin necrosis. For the remaining 18 subjects (6 childrenand 9 adults) the expected ear reshaping was achieved (fluence=84 J/cm2)Table 1; in 3 adults, partial or incomplete reshaping was observed andcorrelated to a lower fluence (70 J/cm2). Those subjects were retreatedat months at 84-J/cm2 fluence and all achieved suitable reshaping (Table2). Again, no postoperative discomfort was reported.

TABLE 1 Our series of 48 reshaped ears using the 1540-nm laser on 24patients Age Fluence Follow-up N (years) Sex (J/cm²) Mold Reshaping Pain(months) 1 6 M 84/84 A/A E/E N/N St/St 2 6 M 84/84 A/A E/E N/N St/St 3 7W 84/84 A/A E/E N/N St/St 4 7 W 84/84 A/A E/E N/N St/St 5 6 W 84/84 A/AE/E N/N St/St 6 8 W 84/84 A/A E/E N/N St/St 7 19 W 84/84 A/A E/E N/NSt/St 8 24 W 84/84 A/A E/E N/N St/St 9 22 W 84/84 A/A E/E N/N St/St 1020 W 84/84 A/A E/E N/N St/St 11 16 W 84/84 A/A E/E N/N St/St 12 18 M84/84 A/A E/E N/N St/St 13 22 M 84/84 A/A E/E N/N St/St 14 22 W 84/84A/A E/E N/N St/St 15 45 W 84/84 A/A E/E N/N St/St 16 24 W 84/84 I/I I/IN/N MR/MR 17 22 W 84/84 I/I I/I N/N MR/MR 18 8 W 84/84 I/I I/I N/N MR/MR19 6 W 84/84 I/I I/I N/N MR/MR 20 6 W 84/84 I/I I/I N/N MR/MR 21 8 M84/84 I/I I/I N/N MR/MR 22 22 M 70/70 A/A I/I N/N SeR/SeR 23 18 W 70/70A/A I/I N/N SeR/SeR 24 22 W 70/70 A/A I/I N/N SeR/SeR M man, W woman,R/L right/left, A appropriate, I inappropriate, E expected, Iincomplete, N none, S slight, M moderate, Se severe, St stable, SRslight recurrence, MR moderate recurrence, SeR severe recurrence

TABLE 2 Three patients underwent a second course of reshaping with a newfluence Age Fluence Follow-up N (years) Sex (J/cm²) Mold Reshaping Pain(months) 22 22 M 84/84 A/A E/E N/N St/St 23 18 W 84/84 A/A E/E N/N St/St24 22 W 84/84 A/A E/E N/N St/St M male, W woman, A appropriate, Eexpected, N none, St stable

EXAMPLE 2

Laser-Assisted Cartilage Reshaping for Treating Ear Protrusions

Materials and Methods

Groups of ten subjects are treated at different wavelengths, number ofpulses, intervals separating pulses, and cumulative fluence levels byLACR. Each subject group receives the same treatment. Pain is assessedby the subjects using a 4-point scale: none, slight, moderate, or severe

Lasers of 532, 755, 1064, 1320, 1540, 2940, and 10600 nm are obtainedfrom Alma Lasers US (Buffalo Grove, Ill.). The lasers are set at 0.1,0.5, 1, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, or 30 J/cm2per pulse (with the length of the pulse chosen so as to determine theamount of energy per pulse) with an interval between pulses of 1, 10,100, 200, 400, 600, 800, or 1000 nanoseconds or 10, 20, 40, 60, 80, 100,200, 400, or 500 milliseconds. The treatment consists of 1, 2, 3, 4, 5,6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 stacked pulses to achieve 0.7,3.5, 7, 21, 28, 42, 56, 70, 84, 98, 112, 126, 140, 154, 168, 182, 196,or 210 J/cm2 cumulative fluence using a 4-mm spot hand piece withintegrated cooling on both sides of the entire helix and concha. Theentire helix and concha are irradiated on both sides. Contact coolingmakes the treatment very tolerable, to the extent that topicalanesthesia is not required (although local anesthetic certainly couldmay be used).

Immediately after irradiation, the ear is placed in a device designed toretain the cartilage structure in the orientation, shape, and/orlocation. The entire procedure takes no more than 15-20 min per ear.Subjects are asked to wear the device at all times for the first 3 weeksand then only at night for an additional 3 weeks. A non-steroidalanti-inflammatory drug (NSAID) is provided to all subjects for 3 days.Ears are checked at days 1, 30, 60, and 90 and photographs are taken.Clinical follow-up at 1 year is obtained via direct contact or over thetelephone (n=2).

Results

Postoperative follow-up is uneventful for all ears. The ear reshaping isachieved No postoperative discomfort is reported.

EXAMPLE 3

Electromagnetic Energy-Assisted Cartilage Reshaping for Treating EarProtrusions

Materials and Methods

Groups of ten subjects are treated at different wavelengths, number ofpulses, intervals separating pulses, and cumulative fluence levels byEMACR. Each subject group receives the same treatment. Pain is assessedby the subjects using a 4-point scale: none, slight, moderate, or severe

Electromagnetic energy emitters of capable of emitting 0.001, 0.005,0.01, 0.05, 0.1, 0.5, 1, 10, 20, 30, 40, and/or 50 MHz are obtained. Theemitters are set at 0.1, 0.5, 1, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24, 26, 28, or 30 J/cm2 per pulse (with the length of the pulse chosenso as to determine the amount of energy per pulse) with an intervalbetween pulses of 1, 10, 100, 200, 400, 600, 800, or 1000 nanoseconds or10, 20, 40, 60, 80, 100, 200, 400, or 500 milliseconds. The treatmentconsists of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 stackedpulses to achieve 0.7, 3.5, 7, 21, 28, 42, 56, 70, 84, 98, 112, 126,140, 154, 168, 182, 196, or 210 J/cm2 cumulative fluence using a 4-mmspot hand piece on both sides of the entire helix and concha. The entirehelix and concha are irradiated on both sides. The treatment is verytolerable, to the extent that topical anesthesia is not required(although local anesthetic certainly could may be used).

Immediately after irradiation, the ear is placed in a device designed toretain the cartilage structure in the orientation, shape, and/orlocation. The entire procedure takes no more than 15-20 min per ear.Subjects are asked to wear the device at all times for the first 3 weeksand then only at night for an additional 3 weeks. A non-steroidalanti-inflammatory drug (NSAID) is provided to all subjects for 3 days.Ears are checked at days 1, 30, 60, and 90 and photographs are taken.Clinical follow-up at 1 year is obtained via direct contact or over thetelephone (n=2).

Results

Postoperative follow-up is uneventful for all ears. The ear reshaping isachieved No postoperative discomfort is reported.

EXAMPLE 4

Electromagnetic Energy-Assisted Cartilage Reshaping for Treating EarProtrusions

Materials and Methods

Groups of ten subjects are treated at different wavelengths, number ofpulses, intervals separating pulses, and cumulative fluence levels byEMACR. Each subject group receives the same treatment. Pain is assessedby the subjects using a 4-point scale: none, slight, moderate, or severe

Electromagnetic energy emitters of capable of emitting 0.3, 0.6, 1, 10,20, 40, 60, 80, 100, 120, 140, 160, 180, and/or 200 MHz are obtained.The emitters are set at 0.1, 0.5, 1, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20,22, 24, 26, 28, or 30 J/cm2 per pulse (with the length of the pulsechosen so as to determine the amount of energy per pulse) with aninterval between pulses of 1, 10, 100, 200, 400, 600, 800, or 1000nanoseconds or 10, 20, 40, 60, 80, 100, 200, 400, or 500 milliseconds.The treatment consists of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,or 15 stacked pulses to achieve 0.7, 3.5, 7, 21, 28, 42, 56, 70, 84, 98,112, 126, 140, 154, 168, 182, 196, or 210 J/cm2 cumulative fluence usinga 4-mm spot hand piece on both sides of the entire helix and concha. Theentire helix and concha are irradiated on both sides. The treatment isvery tolerable, to the extent that topical anesthesia is not required(although local anesthetic certainly could may be used).

Immediately after irradiation, the ear is placed in a device designed toretain the cartilage structure in the orientation, shape, and/orlocation. The entire procedure takes no more than 15-20 min per ear.Subjects are asked to wear the device at all times for the first 3 weeksand then only at night for an additional 3 weeks. A non-steroidalanti-inflammatory drug (NSAID) is provided to all subjects for 3 days.Ears are checked at days 1, 30, 60, and 90 and photographs are taken.Clinical follow-up at 1 year is obtained via direct contact or over thetelephone (n=2).

Results

Postoperative follow-up is uneventful for all ears. The ear reshaping isachieved No postoperative discomfort is reported.

EXAMPLE 5

Trauma Assisted Cartilage Reshaping for Treating Ear Protrusions

Materials and Methods

Groups of ten subjects are treated with different forms of trauma. Thetraumas tested are blunt force, piecing with mirconeedles, heat trauma,and cold trauma. Each subject group receives the same treatment. Pain isassessed by the subjects using a 4-point scale: none, slight, moderate,or severe

The entire helix and concha are traumatized on both sides. A topicalanesthesia or local anesthetic is used to for the application of thetrauma if necessary.

Immediately after trauma, the ear is placed in a device designed toretain the cartilage structure in the orientation, shape, and/orlocation. The entire procedure takes no more than 15-20 min per ear.Subjects are asked to wear the device at all times for the first 3 weeksand then only at night for an additional 3 weeks. A non-steroidalanti-inflammatory drug (NSAID) is provided to all subjects for 3 days.Ears are checked at days 1, 30, 60, and 90 and photographs are taken.Clinical follow-up at 1 year is obtained via direct contact or over thetelephone (n=2).

Results

Postoperative follow-up is uneventful for all ears. The ear reshaping isachieved No postoperative discomfort is reported.

What is claimed is:
 1. A method of shaping or reshaping a cartilagestructure, the method comprising: treating the cartilage structure of asubject by applying electromagnetic energy to the cartilage structurewith an emitter of electromagnetic energy calibrated to emit a totalfluence of from 1 to 60 Joules of electromagnetic energy per squarecentimeter (J/cm²) onto the cartilage structure within 1% of thecalibrated total fluence so as to stimulate chondrogenesis in thecartilage structure; and fitting the treated cartilage structure with adevice that retains the cartilage structure in a desired orientation,shape, and/or location so as to shape or reshape the cartilagestructure.
 2. The method according to claim 1, wherein theelectromagnetic energy has a wavelength of from 250 nm to 1315 nm, 1325nm to 1445 nm or 1455 nm to 1535 nm or 1540 nm at 11 J/cm² or less, or1540 nm at 13 J/cm² or higher, or 1545 nm to 2095 nm or 2105 nm to 10600nm or has a frequency of from 1000 Hz to 200 MHz.
 3. The methodaccording to claim 1, wherein the electromagnetic energy is applied tothe cartilage structure in from 1 to 50 pulses.
 4. The method accordingto claim 3, wherein each pulse is from 1 nanosecond to 1 second inlength.
 5. The method according to claim 3, wherein the interval betweenpulses is from 1 nanosecond to 1 second in length.
 6. The methodaccording to claim 3, wherein the electromagnetic energy applied perpulse is from 1.2 to 60 Joules.
 7. The method according to claim 1,wherein the cartilage structure is selected from the group consisting ofjoints between bones, rib cage, ear, nose, elbow, knee, ankle, bronchialtubes, intervertebral discs, and nasal septum.
 8. The method accordingto claim 7, wherein the cartilage structure is the ear.
 9. The methodaccording to claim 8, wherein the electromagnetic energy is applied toboth sides of the cartilage structure.
 10. The method according to claim9, further wherein the device is fitted to the cartilage structure atall times for 3 weeks, then only at night for an additional 3 weeks. 11.The method according to claim 1, further comprising determining thetotal fluence emitted by the emitter of electromagnetic energy beforetreating the cartilage structure.